Thrombin

Baxter Reports Fourth-Quarter and Full-Year 2023 Results

Retrieved on: 
Thursday, February 8, 2024

Baxter International Inc. (NYSE:BAX), a global medtech leader, today reported results for the fourth quarter and full year ended Dec. 31, 2023, and provided its financial guidance for full-year and first-quarter 2024.

Key Points: 
  • Baxter International Inc. (NYSE:BAX), a global medtech leader, today reported results for the fourth quarter and full year ended Dec. 31, 2023, and provided its financial guidance for full-year and first-quarter 2024.
  • For full-year 2023, net income attributable to Baxter on a U.S. GAAP basis totaled $2.66 billion, or $5.25 per diluted share.
  • In 2023, the company was named to the Dow Jones Sustainability Index (DJSI) North America, which has included Baxter each year since it launched in 2005.
  • For full-year 2024: Baxter expects sales growth of approximately 2% on both a reported and constant currency basis.

Octapharma Announces Availability of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, January 3, 2024

PARAMUS, N.J., Jan. 3, 2024 /PRNewswire/ -- Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.

Key Points: 
  • The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
  • Octapharma has the Balfaxar® production flexibility to ensure consistent supply for hospitals and medical providers.
  • "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future.
  • Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk.

Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Dabigatran Etexilate Accord, dabigatran etexilate, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Dabigatran Etexilate Accord, dabigatran etexilate, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Dabigatran Etexilate Accord, dabigatran etexilate, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised

Centessa Pharmaceuticals Announces New Data from an Additional 52-Weeks of Continuous Treatment from Third Year (Part 5) of Ongoing Phase 2a Study of SerpinPC for the Treatment of Hemophilia

Retrieved on: 
Sunday, December 10, 2023

The data were shared in a poster presentation at the American Society of Hematology (ASH) Annual Meeting on Sunday, December 10, 2023.

Key Points: 
  • The data were shared in a poster presentation at the American Society of Hematology (ASH) Annual Meeting on Sunday, December 10, 2023.
  • SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.
  • These data highlight the strong foundation on which we are advancing SerpinPC in registrational studies for the treatment of hemophilia B.
  • We would like to extend our sincere thanks to everyone involved in this study including the patients, investigators, and site coordinators.”
    Detailed ABR data from Part 5:

New VOYAGER PAD Analyses Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin Across High-Risk and Complex Patient Populations with Peripheral Artery Disease (PAD)

Retrieved on: 
Tuesday, November 14, 2023

TITUSVILLE, N.J., Nov. 14, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of XARELTO® (rivaroxaban [2.5 mg twice daily plus aspirin 100 mg once daily]) over standard of care (aspirin alone). Data from the two analyses demonstrate the role of XARELTO® in treating both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD). Results were presented at the American Heart Association's (AHA) 2023 Scientific Sessions, hosted in Philadelphia, Pennsylvania, November 11-13, 2023.

Key Points: 
  • "These analyses reinforce the consistency of the favorable benefit-risk profile of XARELTO® plus aspirin for patients with vascular disease, regardless of comorbidity.
  • In fragile patients treated with XARELTO® plus aspirin, 6.2% of patients experienced a MALE compared to 10.3% of patients treated with placebo.
  • In patients with PAD only, 11% of patients treated with XARELTO® plus aspirin experienced a MACE versus 9.8% of patients treated with placebo.
  • Overall, the safety of XARELTO® plus aspirin in patients with PAD was consistent regardless of CAD with no significant interactions.

Octapharma's Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, July 26, 2023

Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.

Key Points: 
  • Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.
  • The Phase III, randomized, double-blind, multicenter study was performed at 24 sites in the U.S. and Europe and randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103).
  • We are confident Balfaxar® will be a welcomed treatment for physicians who need to quickly restore patients' coagulation."
  • Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro ®.

Baxter Launches PERCLOT Absorbable Hemostatic Powder

Retrieved on: 
Monday, July 24, 2023

Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced the launch of PERCLOT Absorbable Hemostatic Powder in the U.S. PERCLOT is a passive, absorbable hemostatic powder that is ready to use and designed for patients with intact coagulation to address mild bleeding.1

Key Points: 
  • Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced the launch of PERCLOT Absorbable Hemostatic Powder in the U.S. PERCLOT is a passive, absorbable hemostatic powder that is ready to use and designed for patients with intact coagulation to address mild bleeding.1
    This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20230724490511/en/
    “PERCLOT is a strong complement to Baxter’s leading hemostat portfolio,” said Steve Wallace, president, Advanced Surgery at Baxter.
  • PERCLOT further enhances clinicians’ ability to optimize patient care by addressing a broader range of intraoperative bleeding.
  • Baxter has successfully continued to expand the global commercial presence of PERCLOT since acquiring the product in July 2021 .

Blue Water Biotech Expands Commercial Portfolio by Acquiring Six FDA-Approved Drugs Across Various Treatment Areas

Retrieved on: 
Wednesday, June 14, 2023

Under the terms of the Agreement, Blue Water Biotech, Inc. (“Blue Water” or the “Company”) will purchase the WraSer Assets for a total of $8.5 million cash consideration payable in three tranches: at signing, upon closing and within one year of closing.

Key Points: 
  • Under the terms of the Agreement, Blue Water Biotech, Inc. (“Blue Water” or the “Company”) will purchase the WraSer Assets for a total of $8.5 million cash consideration payable in three tranches: at signing, upon closing and within one year of closing.
  • In addition, WraSer shall receive 1.0 million restricted shares of Blue Water’s common stock on the closing date.
  • The closing of the transaction is subject to certain customary closing conditions, as well as WraSer’s delivery of 2022 audited financial statements for WraSer’s parent company, Legacy-Xspire Holdings, LLC, to Blue Water.
  • Blue Water will assume management of the WraSer Assets during the audit period.

Vega Therapeutics Receives FDA Orphan Drug Designation for VGA039 for the Treatment of von Willebrand Disease

Retrieved on: 
Tuesday, May 23, 2023

Vega Therapeutics , Inc., a clinical stage biotechnology company developing novel therapies for rare blood disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for VGA039 for the treatment of the rare bleeding disorder, von Willebrand disease (VWD).

Key Points: 
  • Vega Therapeutics , Inc., a clinical stage biotechnology company developing novel therapies for rare blood disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for VGA039 for the treatment of the rare bleeding disorder, von Willebrand disease (VWD).
  • By promoting thrombin generation through targeting Protein S, VGA039 addresses a fundamental mechanism of clot formation in VWD and, as a subcutaneously self-administered antibody therapy, has potential to transform VWD treatment.
  • “Receiving orphan drug designation status is an important step for VGA039,” said Gary Patou, MD, Chief Medical Officer of Vega Therapeutics.
  • In preclinical studies, VGA039 has demonstrated efficacy in VWD, as well as in numerous congenital bleeding disorders.